Biologic outcomes in severe asthma patients by smoking status: evidence from SHARP
Abstract
RATIONALE: The efficacy of biologics remains debatable in current or ex- smokers with severe asthma. OBJECTIVES: This study aimed to evaluate responses to biologics by smoking exposure and to assess variations in management practice across Europe. METHODS: This was a retrospective real-world study of adults with severe asthma from 16 European countries assessed at baseline and after 1-year of biologic treatment. Data were collected within the ERS SHARP (Severe Heterogeneous Asthma Research-Patient Centred) registry, applying the OMOP Common Data Model. MEASUREMENTS AND MAIN RESULTS: Of the 3,876 adult patients, 2,383 were never-smokers, 540 ex-smokers (<10 pack-years), 812 (≥10 pack-years), and 141 current-smokers. In all 4 groups, symptom control (ACT≥20/ACQ≤1.5) improved, frequent exacerbations (≥2/year) decreased, asthma quality of life (AQLQ) improved, and oral corticosteroid use decreased. While the starting point sometimes differed, the order of magnitude of change was not statistically different between groups. A country-averaged analysis of the SHARP survey revealed that 29% of participating nations reported opposition to prescribing biologics to current smokers, while 59% expressed dissatisfaction with current treatment guidelines. CONCLUSION: Our study reveals a lower prevalence of biologic therapy among adults with severe asthma who smoke and provides evidence suggesting this practice is unwarranted. Former/current smokers who underwent biologic therapy for one year responded as effectively as never-smokers. Recognising the complexity of nicotine dependence, smoking cessation should remain a central goal in asthma management. This study underscores the need for randomized controlled trials in smokers to enable more robust and inclusive scientific conclusions and guidelines.
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BibTeX
@article{caminati2026biologic,
title = {{Biologic outcomes in severe asthma patients by smoking status: evidence from SHARP}},
author = {Marco Caminati and Jeremy Charriot and Aruna Bansal and Shane Hanon and Renaud Louis and Florence Schleich and Muriel Delvaux and Guy Brusselle and Stéphanie Ziant and Virginie Paulus and Sanja Grle Popovic and Gordana Pavlisa and Marina Lampalo and Celeste Porsbjerg and Kjell Håkansson and Susanne Hansen and Arnaud Bourdin and Eve Klising and Candice Estellat and Caroline Giboin and Dounya Metdaoui and Zsuzsanna Csoma and Dora Lúðvíksdóttir and Giorgio Walter Canonica and Enrico Heffler and Cristina Cardini and Anna Alloni and Iveta Kroica and Kristina Bieksiene and Romain Tching and Anneke ten Brinke and Jacob Sont and Piotr Kuna and Maria Morawska and Florin Mihaltan and Sanja Hromis and Aleksa Golubovic and Mihailo Stjepanovic and Vojislav Ćupurdija and Peter Kopac and Valentyna Yasinska and Fabienne Jaun and Joerg Leuppi and Ebru Damadoglu and Ozlem Goksel and Sabina Skrgat and Ratko Djukanovic and Bilun Gemicioglu},
journal = {American Journal of Respiratory and Critical Care Medicine},
year = {2026},
month = sep,
doi = {10.1093/ajrccm/aamag473},
url = {https://hal.science/hal-05762209v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - Biologic outcomes in severe asthma patients by smoking status: evidence from SHARP
AU - Marco Caminati
AU - Jeremy Charriot
AU - Aruna Bansal
AU - Shane Hanon
AU - Renaud Louis
AU - Florence Schleich
AU - Muriel Delvaux
AU - Guy Brusselle
AU - Stéphanie Ziant
AU - Virginie Paulus
AU - Sanja Grle Popovic
AU - Gordana Pavlisa
AU - Marina Lampalo
AU - Celeste Porsbjerg
AU - Kjell Håkansson
AU - Susanne Hansen
AU - Arnaud Bourdin
AU - Eve Klising
AU - Candice Estellat
AU - Caroline Giboin
AU - Dounya Metdaoui
AU - Zsuzsanna Csoma
AU - Dora Lúðvíksdóttir
AU - Giorgio Walter Canonica
AU - Enrico Heffler
AU - Cristina Cardini
AU - Anna Alloni
AU - Iveta Kroica
AU - Kristina Bieksiene
AU - Romain Tching
AU - Anneke ten Brinke
AU - Jacob Sont
AU - Piotr Kuna
AU - Maria Morawska
AU - Florin Mihaltan
AU - Sanja Hromis
AU - Aleksa Golubovic
AU - Mihailo Stjepanovic
AU - Vojislav Ćupurdija
AU - Peter Kopac
AU - Valentyna Yasinska
AU - Fabienne Jaun
AU - Joerg Leuppi
AU - Ebru Damadoglu
AU - Ozlem Goksel
AU - Sabina Skrgat
AU - Ratko Djukanovic
AU - Bilun Gemicioglu
PY - 2026
DA - 2026/09/22
JO - American Journal of Respiratory and Critical Care Medicine
DO - 10.1093/ajrccm/aamag473
UR - https://hal.science/hal-05762209v1
AB - RATIONALE: The efficacy of biologics remains debatable in current or ex- smokers with severe asthma. OBJECTIVES: This study aimed to evaluate responses to biologics by smoking exposure and to assess variations in management practice across Europe. METHODS: This was a retrospective real-world study of adults with severe asthma from 16 European countries assessed at baseline and after 1-year of biologic treatment. Data were collected within the ERS SHARP (Severe Heterogeneous Asthma Research-Patient Centred) registry, applying the OMOP Common Data Model. MEASUREMENTS AND MAIN RESULTS: Of the 3,876 adult patients, 2,383 were never-smokers, 540 ex-smokers (<10 pack-years), 812 (≥10 pack-years), and 141 current-smokers. In all 4 groups, symptom control (ACT≥20/ACQ≤1.5) improved, frequent exacerbations (≥2/year) decreased, asthma quality of life (AQLQ) improved, and oral corticosteroid use decreased. While the starting point sometimes differed, the order of magnitude of change was not statistically different between groups. A country-averaged analysis of the SHARP survey revealed that 29% of participating nations reported opposition to prescribing biologics to current smokers, while 59% expressed dissatisfaction with current treatment guidelines. CONCLUSION: Our study reveals a lower prevalence of biologic therapy among adults with severe asthma who smoke and provides evidence suggesting this practice is unwarranted. Former/current smokers who underwent biologic therapy for one year responded as effectively as never-smokers. Recognising the complexity of nicotine dependence, smoking cessation should remain a central goal in asthma management. This study underscores the need for randomized controlled trials in smokers to enable more robust and inclusive scientific conclusions and guidelines.
SN - 1073-449X
SN - 1535-4970
ER -